# K013118: Modification to Alpha DX System

- Pathway: 510(k) (Special)
- Applicant: First Medical, Inc.
- Decided: Oct 15, 2001 after 27 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer. The er is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.

Source page: https://510kreport.com/device/K013118
Methodology: https://510kreport.com/methodology